Motif Bio Submits Meeting Request and Package to the U.S. FDA for Iclaprim

Motif Bio plc (AIM/Nasdaq: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced that it has submitted a meeting request and package to the U.S. Food & Drug Administration (FDA) related to the Company’s lead product candidate, iclaprim. In the minutes from a May 3, 2019, Type A meeting, the FDA indicated that an additional clinical trial will be required prior to granting marketing approval of iclaprim. The Company has been encouraged by the FDA to put forth a proposal for such a study. Motif Bio has requested a Type B meeting with the Agency to discuss the proposed study population and design. The Company will provide guidance on when such a meeting will occur once FDA issues the meeting granted letter.  The FDA typically schedules a Type B meeting within 60 days of request, although it can take longer.

https://www.marketscreener.com/MOTIF-BIO-PLC-21452909/news/Motif-Bio-Submits-Meeting-Request-and-Package-to-the-U-S-FDA-for-Iclaprim-28903129/